Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - ropivacaine hydrochloride monohydrate, quantity: 423.2 mg - injection, solution - excipient ingredients: sodium hydroxide; hydrochloric acid; water for injections; sodium chloride - surgical anaesthesia (adults and children over 12 years of age),? epidural block for surgery including caesarean section,? intrathecal anaesthesia,? field block (minor nerve block and infiltration),? major nerve block,analgesia (adults and children over 12 years of age),? continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain,? field block (minor nerve block and infiltration),? continuous peripheral nerve block infusion or intermittent injections for post operative pain management,? continuous wound infusion for postoperative pain management (adults only),analgesia (children aged 0 - 12 years),? caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years,? continuous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years,? peripheral nerve block in children aged 1 up to and including 12 years,for peri- and postoperative pain management.,there are no safety or efficacy data to support the use of ropivacaine actavis for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).

Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - ropivacaine hydrochloride monohydrate, quantity: 158.7 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections - surgical anaesthesia (adults and children over 12 years of age),? epidural block for surgery including caesarean section,? intrathecal anaesthesia,? field block (minor nerve block and infiltration),? major nerve block,analgesia (adults and children over 12 years of age),? continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain,? field block (minor nerve block and infiltration),? continuous peripheral nerve block infusion or intermittent injections for post operative pain management,? continuous wound infusion for postoperative pain management (adults only),analgesia (children aged 0 - 12 years),? caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years,? continuous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years,? peripheral nerve block in children aged 1 up to and including 12 years,for peri- and postoperative pain management.,there are no safety or efficacy data to support the use of ropivacaine actavis for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).

Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - ropivacaine hydrochloride monohydrate, quantity: 423.2 mg - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium chloride; sodium hydroxide - surgical anaesthesia (adults and children over 12 years of age),? epidural block for surgery including caesarean section,? intrathecal anaesthesia,? field block (minor nerve block and infiltration),? major nerve block,analgesia (adults and children over 12 years of age),? continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain,? field block (minor nerve block and infiltration),? continuous peripheral nerve block infusion or intermittent injections for post operative pain management,? continuous wound infusion for postoperative pain management (adults only),analgesia (children aged 0 - 12 years),? caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years,? continuous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years,? peripheral nerve block in children aged 1 up to and including 12 years,for peri- and postoperative pain management.,there are no safety or efficacy data to support the use of ropivacaine actavis for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).

Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - ropivacaine hydrochloride monohydrate, quantity: 52.9 mg - injection, solution - excipient ingredients: hydrochloric acid; sodium chloride; sodium hydroxide; water for injections - surgical anaesthesia (adults and children over 12 years of age),? epidural block for surgery including caesarean section,? intrathecal anaesthesia,? field block (minor nerve block and infiltration),? major nerve block,analgesia (adults and children over 12 years of age),? continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain,? field block (minor nerve block and infiltration),? continuous peripheral nerve block infusion or intermittent injections for post operative pain management,? continuous wound infusion for postoperative pain management (adults only),analgesia (children aged 0 - 12 years),? caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years,? continuous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years,? peripheral nerve block in children aged 1 up to and including 12 years,for peri- and postoperative pain management.,there are no safety or efficacy data to support the use of ropivacaine actavis for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

bioq pharma b.v. - ropivacaine hydrochloride monohydrate 2,116 mg/ml - eq. ropivacaine hydrochloride 2 mg/ml - solution for infusion in administration system - 2 mg/ml - ropivacaine hydrochloride monohydrate 2.116 mg/ml - ropivacaine

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

altan pharma ltd. - ropivacaine hydrochloride monohydrate 2 mg/ml - solution for infusion - 2 mg/ml - ropivacaine hydrochloride monohydrate 2 mg/ml - ropivacaine

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

altan pharma ltd. - ropivacaine hydrochloride monohydrate 2 mg/ml - solution for infusion - 2 mg/ml - ropivacaine hydrochloride monohydrate 2 mg/ml - ropivacaine

Canada - English - Health Canada

pfizer canada ulc - ropivacaine hydrochloride - solution - 5mg - ropivacaine hydrochloride 5mg - local anesthetics

Canada - English - Health Canada

pfizer canada ulc - ropivacaine hydrochloride - solution - 10mg - ropivacaine hydrochloride 10mg - local anesthetics

Canada - English - Health Canada

pfizer canada ulc - ropivacaine hydrochloride - solution - 2mg - ropivacaine hydrochloride 2mg - local anesthetics